Rheos Feasibility Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT01077180
First received: February 25, 2010
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy.


Condition Intervention Phase
Hypertension
Device: Implantation of the Rheos System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rheos Feasibility Trial- A Study of Baroreflex Hypertension TherapyTM in Refractory Hypertension

Resource links provided by NLM:


Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:
  • Rheos Feasibility Study [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]

    To summarize the efficacy of the Rheos System by estimating the reduction of systolic blood pressure associated with activation of the Rheos System at 4 and 13 months post implant when compared to baseline (1-month post implant).

    To describe the safety of the Rheos System by summarizing all system related adverse events and estimating the serious sytem related event-free rate through 4 and 13 months post-implant.



Enrollment: 16
Study Start Date: January 2005
Study Completion Date: October 2010
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Implantation of the Rheos System
    Open label
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be at least 21 years of age.
  2. Have been assessed to have bilateral carotid bifurcations located at or below C3-C4.
  3. Have an office cuff systolic blood pressure greater than or equal to 160 mmHg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmHg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
  4. Must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
  5. Have signed a CVRx approved informed consent for participation in this study.

Exclusion Criteria:

  1. Have been diagnosed with:

    • Baroreflex failure
    • Cardiac bradyarrhythmias
    • Chronic atrial fibrillation
  2. Had a heart transplant
  3. Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
  4. Have Grade C ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
  5. Have prior surgery or radiation in either carotid sinus region.
  6. Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
  7. Are pregnant or contemplating pregnancy during the 13-month follow-up period.
  8. Currently undergoing dialysis.
  9. Have hypertension secondary to a treatable cause.
  10. Have clinically significant cardiac valvular disease.
  11. Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
  12. Are unlikely to survive the protocol follow-up period.
  13. Are enrolled in another concurrent clinical trial.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01077180     History of Changes
Other Study ID Numbers: 360005-001
Study First Received: February 25, 2010
Last Updated: October 28, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014